Natural desiccated thyroid is a treatment that had its first medically documented use in 1891, and successfully. The details of this first and subsequent uses start of page 39 of the Stop the Thyroid Madness book. It rose in popularity and was determined quickly to be a great treatment for hypothyroidism.
In 1906 came the beginning of the FDA’s current regulations with the passage of the Pure Food and Drugs Act. This act was created to prevent the commerce of “adulterated and misbranded food and drugs”.
In 1938 came the Food, Drug and Cosmetic Act which gave the FDA authority to oversee the safety of all three of the latter. Many medications already in use were “grandfathered in”, as was the case of desiccated thyroid.
In the early 1960’s came the Drug Efficacy Study Implementation (DESI) by the FDA which was meant to classify drugs introduced between 1938 and 1962 as either effective, ineffective, or needing further study. That study was completed in 1969.
Then came 2006 and a new Compliance Policy Guide (CPG, updated June 20th of 2006) which targets the remaining unapproved drugs like desiccated thyroid and which ultimately requires the pharmaceuticals which make these drugs to “prove” their effectiveness and safety (i.e. 110 years of millions of patients using this wonderful drug is not enough). The proof comes in an NDA (New Drug Application) and rigorous clinical trials, which are quite expensive.
An important sentence in the CPG is found in Section II A: We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market. In other words, all thyroid patients who know the superiority of desiccated thyroid will be keeping the FDA to task for this.
